FDA 510(k) Applications Submitted by Kevin Ni
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K190941 |
04/10/2019 |
BioCardia 8.5 F Avance Steerable lntroducer |
BioCardia, Inc. |
| K980308 |
01/27/1998 |
ECHOTECH 3D FREESCAN |
ECHOTECH 3D IMAGING SYSTEMS GMBH |
| K990560 |
02/22/1999 |
LIFE IMAGING SYSTEMS, MODEL L3DI |
LIFE IMAGING SYSTEMS, INC. |
| K081512 |
05/30/2008 |
STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE |
MEDTRONIC NAVIGATION, INC. |
| K992931 |
08/31/1999 |
NON-STICK BIPOLAR FORCEPS |
SILVERGLIDE SURGICAL TECHNOLOGIES |
| K013088 |
09/17/2001 |
ECHOTECH EASY 3D FAMILY, ECHOTECH 3D FREESCAN, ECHOTECH EASYARCHIVE, ECHOTECH QUANTICON, ECHOTECH EASYSTRESS |
ECHOTECH 3D IMAGING SYSTEMS, INC. |
| K963807 |
09/23/1996 |
TOMTEC ECHO-SCAN |
TOMTEC IMAGING SYSTEMS, INC. |
| K242791 |
09/16/2024 |
Electric wheelchair (KR-8807) |
Zhejiang Kairui Medical Device Co., Ltd. |
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